Illinois IRB Procedures, Policies, and Processes

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Illinois IRB Procedures, Policies, and Processes

The IRB ensures that appropriate safeguards exist to protect the rights and welfare of research subjects [45 CFR 46.111]. In fulfilling these responsibilities, the IRB reviews all the research documents and activities that bear directly on the rights and welfare of the subjects of proposed research. The application or protocol, the consent/assent document(s), research equipment form, tests, surveys, questionnaires and similar measures, and recruitment documents are examples of documents that the IRB reviews.View IRB Procedures, Policies, and Processes

IRB Membership

IRB members are appointed by the Vice Chancellor for Research after consultation with the IRB chairs and OPRS director. IRB members serve staggered three-year terms and are responsible for being informed on all IRB policies and procedures and applicable laws and regulations. IRB members are expected to review all new cases, to review continuing cases of more than minimal risk and other cases as assigned, and to attend and vote at IRB meetings. The following requirements for the composition of an IRB are based on federal regulations (see 45CFR §46.107-108):

To promote complete and adequate review of research activities commonly conducted by the institution, each University of Illinois at Urbana-Champaign Institutional Review Board (IRB) shall have at least five members with varying backgrounds. If an IRB regularly reviews research that involves a vulnerable category of subjects (such as children, pregnant women, prisoners, people with handicaps, or people with mental disabilities), consideration will be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or of women.

Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.

Each IRB shall include at least one nonaffiliated member, who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

No IRB member may participate in the initial or continuing review of any project in which the member has a conflict of interest, except to provide information requested by the IRB.

An IRB may invite individuals with competence in a special area to assist in the review of issues that require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB.

When reviewing cases involving the Food and Drug Administration (FDA)-regulated articles, at least one physician must be present and eligible to vote on the case.

Federalwide Assurance

The University of Illinois at Urbana-Champaign's Federalwide Assurance number is #00008584 and expires on 08/13/2020.